Clinical Data Associate II

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Clinical Data Associate to contribute to Clinical Data Management activities for assigned studies under supervision. Exact title will depend on experience and skill level.

The role includes supporting data management documentation, CRF design alignment, testing of data systems (EDC/IRT/ePRO), data review, data transfers, and cross-functional collaboration to support study activities, with emphasis on quality and regulatory compliance.

Qualifications

• Minimum 1 year of experience in Clinical Data Management (2+ years preferred).
• Bachelor's degree or higher in a medical or scientific field.
• Strong verbal and written communication skills.
• Experience with clinical data entry system design, development, and maintenance (preferred).
• Experience carrying out data review plans (preferred).

Responsibilities

• Support Clinical Data Management activities for assigned clinical studies under the direction of the Clinical Data Manager
• Support the review, maintenance, and filing of study Data Management documentation
• Participate in design review of Case Report Forms (CRF) and CRF Completion Guidelines (CCG)
• Assist with testing and maintenance of clinical data systems including EDC, IRT, and ePRO
• Perform data review activities under the guidance of the Clinical Data Manager, including data checks and query review
• Prepare data listings and metrics under the guidance of the Clinical Data Manager
• Assist with data transfers and reconciliation activities
• Collaborate with cross-functional team members and external to support study activities
• Track activities and escalation data issues, risks, or delays to the Clinical Data Manager
• Adhere to internal standards and regulatory requirements (ICH, GxP, CDISC, 21 CFR Part 11)
• Other duties as required

Skills

Analytical thinking

Verbal communication

Written communication

Attention to detail

Multitasking

Interpersonal skills

Self-motivation

Education

Bachelor's degree or higher in a medical or scientific field

Tools

Microsoft Office Suite

File sharing software

Online conferencing applications

Job description

Viking Therapeutics is a clinical-stage biotechnology company advancing a next-generation portfolio of therapies for obesity and metabolic disease. We are developing treatments to help patients achieve meaningful, lasting improvements in health by treating obesity first. Our therapies are designed to support the long‑term health benefits of weight loss, including cardiovascular health, improved physical function, and quality of life.

Description

The Clinical Data Associate will contribute to the performance of Clinical Data Management activities for assigned studies according to protocols, industry standards and guidelines, and Standard Operating Procedures (SOPs). Exact title (Clinical Data Associate II or Senior Clinical Data Associate) will depend on experience and skill level.

Essential Duties and Responsibilities

The main responsibilities of this role include but are not limited to the following:

• Support Clinical Data Management activities for assigned clinical studies under the direction of the Clinical Data Manager
• Support the review, maintenance, and filing of study Data Management documentation
• Participate in design review of Case Report Forms (CRF) and corresponding CRF Completion Guidelines (CCG) to align with protocol requirements and data collection standards
• Assist with the testing and maintenance of clinical data systems, including Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient-Reported Outcomes (ePRO)
• Perform data review activities under the guidance of the Clinical Data Manager, including execution of data checks, query review, and issues tracking
• Prepare data listings and metrics under the guidance of the Clinical Data Manager
• Assist with data transfers and reconciliation activities in accordance with defined procedures
• Collaborate with cross‑functional team members and external to support study activities as directed
• Track activities and escalation data issues, risks, or delays to the Clinical Data Manager as appropriate
• Adhere to Clinical Data Management internal standards and applicable regulatory and industry requirements, including ICH guidelines, Good Practice guidelines (GxP), CDISC standards, and 21 CFR Part 11
• Other duties as required

Requirements

Education and Experience

• Minimum of 1 years of experience in Clinical Data Management (>2 years preferred)
• Bachelor's degree or higher in a medical or scientific field
• Experienced verbal and written communication skills
• Preferred: Experienced in clinical data entry system design, development, and maintenance
• Preferred: Experienced in carrying out data review plans

Knowledge and Skills

• Proficient in Microsoft Office Suite, file sharing software, and online conferencing applications
• Strong analytical and problem‑solving skills
• Strong verbal and written communication skills
• Excellent professional interpersonal skills with the ability to work in a positive and collaborative fashion
• Ability to manage multiple tasks at once and maintain strong attention to detail
• Self‑motivated, dependable individual with self‑confidence and a positive attitude